MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TRAPLINER; CATHETER

Model Number	5567
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: trapliner was defective during a recent procedure.According to clinical, it detached during the procedure.Several good faith attempts have been made to receive additional information regarding how the trapliner detached and patient condition with no response from hospital.
Additional Manufacturer Narrative
An investigation has been opened to review device history record and risk documentation.A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
One-unit of trapliner was returned for evaluation.Blood particulates were noted on the catheter.Weld joint separation was observed.Crimp damages was observed on the rx lumen.The top-level assembly traveler was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly and performance specifications.Case details were reviewed.A patient underwent a procedure for cto.A trapliner was used in the case.The trapliner detached during the procedure.The damages are likely to have occurred during use in the procedure along with other devices when operated against resistance.Per ifu states the following warning and precaution: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.Exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage or kinking.Do not apply torque to the catheter during delivery, as catheter damage may result.Additional information was requested from the account.A response was received.Lesion type is unknown.No part of the trapliner was left in the vessel.Patient is fine post procedure.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: angela meister ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564253
• MDR Report Key: 15171074
• Report Number: 2134812-2022-00048
• Device Sequence Number: 6330355
• Product Code: DQY
• UDI-Device Identifier: 10841156102135
• UDI-Public: 10841156102135
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2024
• Device Model Number: 5567
• Device Catalogue Number: 5567
• Device Lot Number: 717234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown